Cleared Traditional

K030016 - TEOAE25

K030016 is an FDA 510(k) clearance for TEOAE25, manufactured by Interacoustics A/S, Assens. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K030016 · Interacoustics A/S, Assens · Ear, Nose, Throat device
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Mar 2003
Decision
85d
Days
Class 2
Risk

K030016 is an FDA 510(k) clearance for the TEOAE25. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Interacoustics A/S, Assens (Eden Prairie, US). The FDA issued a Cleared decision on March 28, 2003 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Interacoustics A/S, Assens devices

FDA 510(k) Submission Details - K030016

510(k) Number K030016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2003
Decision Date March 28, 2003
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 89d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K030016.
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
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COCHLEA-SCAN / COCHLEA-SCAN PLUS
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BIO-LOGIC INSERT EARPHONES
K031352 · Bio-Logic Systems Corp. · Jul 2003
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · Bio-Logic Systems Corp. · Jun 2002
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K984547 · Resound Corp. · Mar 1999
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K974076 · Bio-Logic Systems Corp. · Jan 1998